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Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy

Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy for Visualisation of Endoscope Localisation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00258531
Enrollment
360
Registered
2005-11-24
Start date
2003-06-30
Completion date
2005-06-30
Last updated
2006-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any Symptom Requiring Colonoscopy

Brief summary

* A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for routine use during colonoscopy. * No randomised trials have been performed to evaluate if, and to what extent, the use of this technology may improve the coecal intubation rate and reduce the patient's experience of discomfort and pain by making the insertion of the endoscope easier

Detailed description

Endoscopist at different level of experience are to participate. Patients routinely referred to the outpatients department for colonoscopy are asked to participate in a randomised trial where coecal intubation rate and pain experienced by the patient are end-point. Written informed consent is obtained. For each endoscopist, allocated patients are randomised to colonoscopy with no imaging technique (usual care) or using the 3-dimentional imager.

Interventions

DEVICEOlympus ScopeGuide®, 3-dimentional magnetic imager

Sponsors

Sykehuset Telemark
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* A successive series of patients referred for routine colonoscopy

Exclusion criteria

* Age under 18 years * Pregnant women * Persons with pacemaker * Unwillingness to restrict sedation to on demand * Inability to understand the information given

Design outcomes

Primary

MeasureTime frame
Pain experienced during colonoscopy

Secondary

MeasureTime frame
Coecal intubation rate

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026